MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reporter had indicated that product will not be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the device was worn and fractured.Attempt for further information has been made, but no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The returned instrument exhibits signs of repeated use (nicked or gouged) and the locking feature is fractured on the medial & lateral side of the post.Not all pieces were returned.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Evaluation of the returned device identified the fracture was consistent with the tasp fractures analyzed in a zrm.The zrm identified that the common failure modes for the tasp devices include either bending overload or low cycle fatigue culminating in bending overload as evident by the presence of hackle marks, river lines and striations features on the fracture surface if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10793338
• MDR Text Key: 214823967
• Report Number: 0001822565-2020-03693
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42517600303
• Device Lot Number: 62957073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1